NCT05060822进行中（未招募）2 期
A Phase II, Multi-center, Randomized, Placebo-controlled (Double-blind Design), Active Comparator-controlled (Open-label Design), Parallel-group, Dose-finding Study, to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With IPF
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 24 in %FVC compared with placebo
研究概览
简要总结
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
placebo-controlled (double-blind design), active comparator-controlled (open-label design)，parallel-group
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this clinical study and sign the ICF before the study begins;
- •Aged 40-80 (including 40 and 80) ;
- •Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures;
- •Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018);
- •FEV1/FVC ≥ 0.7;
- •FVC ≥ 45% predicted;
- •DLCO corrected for Haemoglobin (Hb) ≥ 30% predicted of normal;
- •In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit.
排除标准
- •In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization;
- •Interstitial lung disease caused by other known causes;
- •Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening;
- •Expected to receive lung transplantation during the study;
- •Expected survival is less than 6 months;
- •History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma);
- •Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4);
- •History of unstable or worsening heart disease within 6 months before screening;
- •Cannot perform 6MWT or PFT;
- •Allergic to any component of HEC585 Tablets or pirfenidone tablets;
- •Participated in other clinical study and received the last dose within 3 months before screening;
- •Pregnant or breastfeeding;
- •History of smoking within 3 months before screening or are unwilling to quit smoking during the study;
- •Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study;
- •History of drug abuse within 6 months before the screening;
- •Family or personal history of QT prolongation syndrome;
- •Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.
- •TBil > 1.5 × ULN or AST or ALT > 2 × ULN;
- •CLcr < 50 mL/min;
- •Human immunodeficiency virus (HIV) antibody is positive;
- •Uncontrolled hepatitis B virus infection or hepatitis C virus infection;
- •QTcF > 480 ms.
- •Subjects have received any of the following treatments within 28 days before randomization:
- •Any cytotoxic drug or immunosuppressant
- •Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at > 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at > 600 mg/d.
- •Moderate and strong inhibitor or strong inducer of CYP1A
- •Strong inducers or strong CYP3A4 inhibitors.
研究组 & 干预措施
placebo
Placebo Comparator
Drug: placebo once daily, up to 24 weeks-120 weeks
干预措施: Placebo (Drug)
HEC585 dose B
Experimental
Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks
干预措施: HEC585 (Drug)
HEC585 dose A
Experimental
Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks
干预措施: HEC585 (Drug)
HEC585 dose C
Experimental
Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks
干预措施: HEC585 (Drug)
pirfenidone
Active Comparator
Drug: pirfenidone three times a day (target dose), up to 24 weeks
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Change from Baseline to Week 24 in %FVC compared with placebo
时间窗: 24 Weeks
change in %FVC, measured using Spirometer, from baseline to week 24
次要结局
- Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone(12 Weeks)
- Change from Baseline to Week 24 in %FVC compared with Pirfenidone(24 Weeks)
- Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%(24 Weeks)
- Changes of 6MWT results(12 Weeks, 24 Weeks)
- Changes of resting SpO2(12 Weeks, 24 Weeks)
- IPF related mortality(24 Weeks)
- Changes of DLco (Hb correction)(12 Weeks, 24 Weeks)
- Changes of SGRQ scores(12 Weeks, 24 Weeks)
- Time to first acute IPF exacerbation(24 Weeks)
- All-cause mortality(24 Weeks)
研究者
研究点 (1)
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